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A district court has handed a preliminary injunction to EOFlow, blocking it from selling products developed using proprietary information derived from insulin pump maker Insulet — the decision arriving as Medtronic is slated to pay $738 million to acquire EOFlow. Read More
HistoSonics’ Edison System, which uses focused ultrasound to mechanically destroy and liquify unwanted liver tissue and tumors, has received de novo marketing authorization from the FDA and is the first histotripsy platform available in the U.S. Read More
Guidance updates, Novo Nordisk complaint against semaglutide compounders tossed, and AdvaMed forms new digital tech division, in this edition of Quick Notes. Read More
Pfizer announced that the FDA has designated Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab), giving pharmacists the ability to substitute it for Humira without intervention from the prescribing clinician. Read More
The FDA has revised the Manual of Policies and Procedures (MAPP) for ANDA assessment practices with changes intended to decrease the number of review cycles needed for approval. Read More
In a move to strengthen its KRAS-targeting oncology portfolio, Bristol Myers Squibb is buying Mirati, the company that developed and launched Krazati (adagrasib), a best-in-class molecule that, when combined with a PD-1 inhibitor, targets non-small cell lung cancers harboring the common mutation. Read More
Alnylam Pharmaceuticals today announced that the FDA has issued a complete response letter (CRL) on its supplemental New Drug Application (sNDA) for Onpattro (patisiran) for the treatment of cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis and will no longer pursue the expanded indication. Read More
The FDA’s plan to modernize its IT infrastructure features several improvements that will benefit clinical trials and sponsors, including upgrades to data-sharing and electronic submissions, support for responsible use of AI/machine learning (ML) and increased collaboration between the agency and industry. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
Cancer centers in the U.S. are still grappling with shortages of critical drugs, according to a new survey by the National Comprehensive Cancer Network. Read More
The FDA “remains unsatisfied” with Philips Respironics’ handling of the recall of its 15 million ventilators, bilevel positive airway pressure (BiPAP) machines, and continuous positive airway pressure (CPAP) machines. Read More
This year, those making combination products find themselves in a swirl of potentially confusing regulations and standards regarding risk management. Read More